Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection with Borderline Vascularity

Active, not recruiting

• Conditions: Chronic Limb Threatening Ischemia
• Interventions: Other: PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY

• Registration Number: NCT05553509
• Lead Sponsor: Assiut University

Brief Summary

Observe Timing to complete healing of wounds \& Limb salvage in both cohorts those who are undergoing Debridement only and those who are undergoing Debridement plus PTA

Detailed Description

Secondary Aims of the study include Length of hospital stay , Necessity of further intervention(Whether a Revascularization Procedure or More Debridement sessions) , Incidence of MACE (Major Adverse Cardiovascular Events) in both groups

Study Timeline

• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-23
• Study Start: 2023-01-01
• Status Verified: 2024-11
• Primary Completion: 2024-11-01
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-26
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients will be included in this study are those suffering from DFUs; and Borderline Ischemia (BLI) / Borderline Vacularity with (Rutherford Grade "I" Categories "2&3") when they have a borderline ankle systolic pressure

Exclusion Criteria

• All patients with (CLI) and DFUs as they are indicated for urgent re-vascularization.

Severely infected/ gangrenous wounds requiring amputation hindering possible limb salvage.

Lesions lying within or adjacent to an aneurysm; Non diabetic cases with foot ulcers; Arteritic lesions;(Vasculitic Patients). Patients had prior major amputation, bypass surgery, and endarterectomy on any vessel of the ipsilateral (target) extremity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ANGIOPLASTY GROUP	PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY	All patients undergoing PTA are going to be classified according to GLASS staging system
DEBRIDEMENT GROUP	PER CUTANEOUS TRANSLUMINAL ANGIOPLASTY	The most commonly used technique for diabetic foot ulcers is sharp or surgical debridement using a scalpel, tissue forceps or similar instruments. It should be sufficiently extensive to remove all infected and necrotic tissue;

Primary Outcome Measures

Name	Time	Method
Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection With Borderline Vascularity	1 YEAR	1. Observe the timing to complete wound healing in both cohorts those with Debridement only \& those with Debridment plus PTA; 2. Observe the Rate of limb salvage in both groups

Secondary Outcome Measures

Name	Time	Method
Clinical Outcomes Following Surgical Debridement of Diabetic Foot Infection With Borderline Vascularity	1 YEAR	1-Observe incidence of MACE In both cohorts Observe necessity for further interventions in both cohorts 3-Observe the length of hospital stay in both groups

Trial Locations

Locations (1)

Department of vascular surgery - Assiut University Hospital; 🇪🇬 Assiut, Egypt